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Sterile Powder Free Nittile Examination Gloves (Blue, Black and White Colors) is a disposable device intended for medical purposed that is worn on the examiner's hand to prevent contamination between patient and examiner.

Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)

The provided text is an FDA 510(k) clearance letter for "Sterile Powder Free Nitrile Examination Gloves." This document does not contain information about acceptance criteria or a study proving that a device (in the context of an AI/software medical device) meets acceptance criteria.

The information you've requested typically applies to AI/ML (Artificial Intelligence/Machine Learning) or diagnostic medical devices that require performance evaluation against specific metrics (e.g., sensitivity, specificity, AUC). General medical devices like examination gloves are cleared based on substantial equivalence to predicate devices and meeting established performance standards (e.g., standards for tensile strength, barrier integrity, biocompatibility, sterility) through laboratory testing, not through clinical or reader studies that involve humans interacting with an AI or interpreting medical images.

Therefore, I cannot fulfill your request using the provided text. The document is strictly about the regulatory clearance of a physical medical device (gloves) and does not describe the kind of performance study you are asking about.

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The glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with Chemotherapy drugs and fentanyl citrate in accordance with ASTM D6978.

The subject device is Nitrile Examination Gloves Sterile with Chemotherapy drugs and fentanyl citrate claims. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and sterile. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for permeability to chemotherapy drugs and fentanyl citrate per ASTM D6978-05(2019).

The document provided is a 510(k) Premarket Notification from the FDA for "Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate." This document primarily focuses on demonstrating substantial equivalence to a predicate device, specifically by adding a claim for fentanyl citrate permeation. It performs non-clinical testing to support this claim, rather than a study involving AI or human readers for diagnostic purposes.

Therefore, many of the requested details regarding AI device acceptance criteria, human reader studies, and AI-specific ground truth establishment are not applicable to this submission. This is a clearance for a physical medical device (gloves), not a diagnostic AI/ML device.

However, I can extract the relevant information regarding the device's acceptance criteria and the non-clinical study conducted to prove it meets those criteria.

Acceptance Criteria and Study for Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

This medical device is a physical product (examination gloves), not an AI/ML diagnostic tool. The "acceptance criteria" here refer to the physical and chemical performance standards for the gloves, and the "study" refers to non-clinical bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the re-submitted device (K232039) are based on relevant ASTM and ISO standards, and for chemotherapy and opioid drug permeation, specific minimum breakthrough times (BDT). The reported device performance indicates that the gloves passed all these criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the exact sample sizes used for each physical or chemical test. However, for tests like "Freedom from holes," it refers to AQL (Acceptable Quality Level) 2.5, which implies a sampling plan according to ASTM D5151-19. Similarly, other ASTM and ISO standards followed for physical properties and biocompatibility would specify sample sizes.

The data for these tests would be generated prospectively as part of product development and quality control for the submission. The country of origin for the data generation is implied to be China, given the manufacturer's location.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This concept is not applicable here. Ground truth in the context of this submission refers to the established standards and methodologies of the ASTM and ISO tests (e.g., how to measure tensile strength, how to test for permeation). These are standardized laboratory tests, not subjective expert interpretations of images or clinical outcomes. The "experts" are the laboratory personnel who perform these tests according to the published standards.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human readers or subjective interpretations requiring adjudication. The tests have predefined, objective measurement protocols.

5. If a Multi Reader Multi Case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical medical device (gloves), not an AI-assisted diagnostic tool. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. There is no algorithm or AI component in this device. Performance is measured directly through bench testing.

7. The type of ground truth used

The "ground truth" for this device's performance is established by objective, standardized laboratory measurements against predefined performance specifications stated in ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards. Specifically:

• Physical Properties: Measured values (e.g., length, width, thickness, tensile strength, elongation) are compared directly against minimum/maximum thresholds defined in ASTM D6319-19 and ASTM D412-16.
• Freedom from holes: Determined by water leak testing according to ASTM D5151-19, with acceptance based on AQL 2.5.
• Powder Residue: Quantified according to ASTM D6124-06 (2017) against a maximum limit.
• Chemical Permeation: Breakthrough Time (BDT) is measured for specific chemotherapy drugs and fentanyl citrate according to ASTM D6978-05 (2019) and compared against specified minimum times.
• Biocompatibility: Assessed through in-vitro/in-vivo tests for irritation, sensitization (ISO 10993-10:2010), and acute systemic toxicity (ISO 10993-11:2017) to ensure no adverse biological reactions.

8. The Sample Size for the Training Set

Not applicable. As this is not an AI/ML device, there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for an AI/ML algorithm.

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Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978 standards.

The subject device is Nitrile Examination Gloves Sterile with Chemotherapy drugs claims. The subject device is a patient examination glove made from nitrile latex compound, blue color, powder free and sterile (Per 21 CFR 880.6250, class I). The device is direct contact and not to be worn for more than 24 hours. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility per 10993-10, 10993-11 and permeability to chemotherapy drugs per ASTM D6978-05(2019).

The provided document is a 510(k) Premarket Notification from the FDA regarding Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs.

This document does not describe the acceptance criteria and study proving a software algorithm device meets these criteria, but rather the acceptance criteria and test results for a physical medical device (examination gloves).

Therefore, many of the requested categories in your prompt (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, etc.) are not applicable to this type of device and the information provided in the 510(k) summary.

However, I can extract the relevant information about the acceptance criteria and the device's performance based on the provided document.

Device: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs

Type of Device: Physical Medical Device (Examination Gloves), Class I, reserved

Study Purpose: To demonstrate substantial equivalence to a predicate device (Riverstone Resources SDN BHD. Nitrile Examination Glove, Sterile Tested for use with Chemotherapy Drugs Claim, White (K190725)) by verifying that the subject device meets specific performance standards and has similar technological characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

The document presents several tables detailing the acceptance criteria (standards/specifications) and the results indicating that the device meets these criteria.

(Note: For chemotherapy drug permeation, the "Acceptance Criteria" are implied by comparison to the predicate device and showing equivalent or better performance. The exact criteria are not explicitly stated for each drug beyond the measured BDT.)

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated as a number of "cases" or "samples" in the way a software algorithm test set would be. The testing is based on batches of gloves or representative samples according to the referenced ASTM/ISO standards. For example, "Freedom from holes" testing follows an AQL (Acceptance Quality Limit) which implies a sampling plan.
• Data Provenance: The tests are non-clinical and conducted based on international standards (ASTM, ISO). The manufacturer is Grand Work Plastic Products Co., Ltd, located in Donggao Industrial Zone, Zanhuang, Hebei, China. The testing would have been performed there or at certified labs used by the manufacturer. The data is retrospective in the sense that it was collected as part of the device's development and qualification prior to the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The "ground truth" for this physical device's performance (e.g., tensile strength, breakthrough time) is established by adherence to standardized physical and chemical testing methods (ASTM, ISO standards), not by human expert consensus or clinical judgment in the traditional sense of diagnostic AI. These standards define the test procedures and acceptance limits.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study requiring human reader adjudication. Performance is measured by laboratory equipment and standard protocols.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-based diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI-based diagnostic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" is established through standardized physical, chemical, and biological testing methods as defined by:

• ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves)
• ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves)
• ASTM D6124-06(2017) (Standard Test Method for Residual Powder on Medical Gloves)
• ASTM D6978-05(2019) (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs)
• ISO 10993-10:2010 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)
• ISO 10993-11:2017 (Biological evaluation of medical devices - Part 11: Tests for systemic toxicity)

8. The sample size for the training set

Not applicable. This is not a machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not a machine learning device.

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Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue is a disposable device intended for medical purposes that is worn on the examiner 's hand or finger to prevent contamination between the examiner and the patient.

The subject device of this submission is a Nitrile Examination Glove. The glove is non-sterile and meets the recommendations of ASTM 6319-10. The device is Blue in color.

This document is a 510(k) Premarket Notification for Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue. It demonstrates substantial equivalence to a predicate device (K112012). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance specifications of the glove and the testing conducted to show compliance with those specifications and equivalence to the predicate device.

Here's an breakdown of the information requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents several characteristics and their corresponding standards/performance for the new device (K162510) and the predicate device (K112012). This can be structured as follows:

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document refers to "Inspection Level-S-2" and "Inspection Level-G-1" with associated AQLs (Acceptance Quality Limits) for various tests (e.g., Dimensions, Physical Properties, Freedom from Pinholes). These imply specific sampling plans outlined in the relevant ASTM standards (ASTM D 6319-10, ASTM D 5151-06, etc.). However, the exact number of units tested is not explicitly stated in this summary document.
• Data Provenance: Not explicitly stated in terms of country of origin of the data or whether it was retrospective/prospective. As this is a premarket submission for a physical device, the testing would have been conducted in a lab environment.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• This is not applicable in the context of this device. This document is about a physical medical device (gloves), not an AI/software device requiring expert interpretation of medical images or data. The "ground truth" for glove performance is established by adherence to specified physical and chemical characteristics and recognized ASTM and ISO standards, not by expert consensus on clinical interpretation.

4. Adjudication Method for the Test Set

• Not applicable. The "ground truth" is determined by objective physical and chemical testing methods (e.g., measuring dimensions, tensile strength, performing water leak tests, chemical residue analysis, biocompatibility assays), not through human adjudication of differing interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC study was not done. This type of study is relevant for AI/imaging devices where human reader performance is a key metric. For examination gloves, the focus is on physical and chemical properties and safety/performance equivalence.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This is not an algorithm or AI device. The "performance" is the inherent physical and chemical properties of the glove.

7. The Type of Ground Truth Used

• The ground truth for this device is based on objective, standardized measurements and test methods defined by recognized national and international standards, primarily ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards. This includes:
  • Physical Specifications: Dimensions (length, width, thickness), tensile strength, elongation.
  • Functional Testing: Freedom from pinholes (water integrity).
  • Chemical Analysis: Powder residue.
  • Biocompatibility Testing: Dermal sensitization and primary skin irritation, conducted according to ISO 10993-10 and 16 CFR Part 1500.

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As above, this is not a machine learning or AI device.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim

This document is a 510(k) premarket notification from the FDA regarding "Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim."

The document does not describe the acceptance criteria and a study for an AI-powered device. Instead, it outlines the performance of medical gloves against chemotherapy drug permeation. Therefore, most of the requested information regarding AI device studies cannot be extracted.

However, I can provide the acceptance criteria and reported device performance related to chemotherapy drug permeation for the gloves as presented in the document.

1. A table of acceptance criteria and the reported device performance

For the specific context of these gloves and chemotherapy drug permeation, the "acceptance criteria" appear to be implied by the minimum breakthrough detection times. The device's performance is the reported breakthrough time for each drug.

Note: The phrase "minimum breakthrough detection time" in the table heading implies these are the observed times. The standard ASTM D6978-05 would define the methodology and potential performance requirements, but the document itself doesn't explicitly state a pass/fail threshold for these times. However, the subsequent note highlights drugs with "extremely low permeation times of less than 60 minutes," suggesting a 60-minute threshold might be implicitly relevant for practical use considerations.

The document does not provide information for the following points as they are typically relevant for AI/software-as-a-medical-device (SaMD) studies, not for the physical examination gloves described:

2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

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The Non Sterile. Powder Free Nitrile Examination Gloves [{8603F (AD) Blue Color, 8611F (M) Blue Color, 8603F (Y4) Blue Color, 8613F Blue Color, 8603F (H) Blue Color, 8612F (C) Blue Color, 8604T Black Color and 8617F White Color] is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Non Sterile, Powder Free Nitrile Examination Gloves [(8603F (AD) Blue Color, 8611F (M)Blue Color, 8603F (Y4) Blue Color, 8613F Blue Color, 8603F (H) Blue Color, 8612F (C) Blue Color, 8604T Black Color and 8617F White Color] meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. This device is for over-the counter single use. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.

The provided document describes the performance data for various models of Non-Sterile, Powder Free Nitrile Examination Gloves from YTY Industry (MANJUNG) SDN. BHD. based on ASTM and FDA standards. This is not an AI/ML device, therefore, the information requested in points 2, 3, 4, 5, 6, 7, 8, and 9 are not applicable.

Here's the summary of the acceptance criteria and reported device performance:

1. A table of acceptance criteria and the reported device performance

Study Proving Device Meets Acceptance Criteria:

The study summarized in the document is a series of non-clinical tests performed on the Non-Sterile, Powder Free Nitrile Examination Gloves (across various models and colors).

• Standards Used: The performance of the devices was evaluated against the following standards:

  • ASTM Specification D6319-10, Standard Specification for Nitrile Gloves for Medical Application.
  • FDA 1000ml Water Leak Test (ASTM D5151-06 (2011) for watertightness with AQL GII 2.5).
  • ISO 10993-10 for Primary Skin Irritation and Dermal Sensitization (Biocompatibility).
  • ASTM-D6124-10 (Reapproved 2011) for Residual Powder.

• Test Results: The table above details the specific performance results for each characteristic, demonstrating that all tested models of the gloves met or exceeded the specified acceptance criteria for dimensions, physical properties (tensile strength, ultimate elongation, before and after aging), freedom from holes, powder-free status (moisture content, residual powder), and biocompatibility.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states for "Freedom from holes" that the sample size for the water leak test was 80 gloves per lot, with a lot size of 16,000 gloves. The data provenance is not explicitly stated in terms of country of origin of the data or whether it was retrospective or prospective. However, the manufacturer is stated as YTY INDUSTRY (MANJUNG) SDN. BHD. from Malaysia. The tests are non-clinical, implying they were likely conducted in a controlled lab environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the device is not an AI/ML device. The ground truth is established by standardized testing protocols (ASTM, ISO, FDA tests), not by expert consensus in the human interpretation sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the device is not an AI/ML device. The "ground truth" is determined by objective measurements and standardized testing procedures.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable as the device is not an AI/ML device and human "readers" or interpretations are not part of its function or evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance evaluation of these gloves is defined by objective measurements and adherence to international and national standards (ASTM, ISO, FDA specifications) for physical properties, barrier integrity, and biocompatibility. This includes measurements of length, width, thickness, tensile strength, elongation, freedom from holes (water leak test), moisture content, residual powder, and biological response (skin irritation and sensitization).

8. The sample size for the training set
This information is not applicable as the device is not an AI/ML device. There is no concept of a "training set" for physical products like examination gloves in this context.

9. How the ground truth for the training set was established
This information is not applicable as the device is not an AI/ML device.

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A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Non sterile, Powder free Nitrile Examination Glove, Blue.

The provided text describes a 510(k) summary for a Non-sterile, Powder-free Nitrile Examination Glove, Blue. This is a medical device, and the information presented is for its regulatory clearance, not a study evaluating an AI device or a diagnostic tool. Therefore, many of the requested categories (like sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, etc.) are not applicable to this type of device and its regulatory submission.

The document focuses on demonstrating that the new glove is "substantially equivalent" to an already legally marketed predicate device by meeting established performance standards.

Here's an analysis of the provided information, addressing the applicable categories:

1. Table of Acceptance Criteria and Reported Device Performance

Note: "ASTM D 6319-10" refers to "Standard Specification for Nitrile Examination Gloves for Medical Application," which outlines the specific acceptance criteria (e.g., minimum tensile strength, maximum pinhole AQL, etc.) for each characteristic. The document states the device "Meets" or "Passes" these standards.

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified in the provided text. The testing for glove performance standards like ASTM D 6319-10 typically involves taking samples from production lots. The specific number of gloves tested for each characteristic (e.g., dimensions, tensile strength, freedom from holes) is defined by the ASTM standard itself and quality control procedures, but this detail is not present in the 510(k) summary.
• Data Provenance: The manufacturer is Siam Sempermed Corp., Ltd, located in Songkhla, Thailand. Therefore, the data would have originated from their testing facilities in Thailand. The data is based on non-clinical performance testing of the device's physical and biocompatibility characteristics, conducted to demonstrate compliance with the ASTM standard. This is prospective data generated for the purpose of the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. For this type of device (medical glove), "ground truth" is established by adherence to established, objective, and quantitative physical and chemical standards (e.g., ASTM D 6319-10, biocompatibility testing protocols). There are no human "experts" interpreting results like in an image analysis or diagnostic study to establish a ground truth in the typical sense. Laboratory technicians and quality control personnel perform the tests according to standardized protocols.

4. Adjudication method for the test set

• Not Applicable. Adjudication is typically used in studies where there is subjective interpretation or disagreement among observers (e.g., radiologists). For objective glove performance testing, the results are quantitative measurements compared directly against a standard. If a test fails, it fails; there is no 'adjudication' process.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• Not Applicable. MRMC studies are used to evaluate diagnostic performance with human readers. This document describes a physical medical device (a glove), not a diagnostic or AI-driven system.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not Applicable. This device is a physical product and does not involve algorithms or AI.

7. The type of ground truth used

• The "ground truth" for this device's performance is established by objective physical and chemical measurements compared against the acceptance criteria defined by recognized consensus standards, specifically ASTM D 6319-10 for physical properties, and standard biocompatibility testing protocols (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization). These are quantitative, laboratory-based measurements.

8. The sample size for the training set

• Not Applicable. This is not an AI or machine learning device; therefore, there is no "training set."

9. How the ground truth for the training set was established

• Not Applicable. As there is no training set, this question is not relevant.

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This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Sterile, Powder Free Nitrile Examination Gloves, Blue

I'm sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for "Sterile, Powder Free Nitrile Examination Gloves, Blue." It does not contain information about acceptance criteria or a study that proves a device meets such criteria. Therefore, I cannot fulfill your request for that specific information based on the input given.

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